|Home Director (Training) Services Training Overview Curriculum Biostatistics Curriculum SAS Programming Training Schedule TLF Samples Contact Us|
Curriculum: Biostatistics Course Outline
Participants for training in Biostatistics should possess at least a Masters degree in Statistics, Biostatistics, Mathematics, Agricultural Statistics, or related discipline. A PhD will be an advantage. Participants must be proficient in Base module of SAS Software.
1. Introduction to New Drug Development Process (2 hours)The purpose of this lecture is to familiarize the participants with new drug development process, Clinical Trials Phases (I, II, III, IIIa, IIIb, IV), and various terminology commonly used in the pharmaceutical and healthcare industry, such as NDA, BLA, Label, Patent Licensing, ICH, GCP, FDA, EMPEA, 21 CFR Part 11, Label Update, Ethical Committee, IRB, DSMB, ISE, ISS, SCE, SCS, Standard Operating Procedures (SOP), etc.
2. Clinical Trials Activities - Brief Details (2 hours)This lecture will provide information on various activities in clinical trials, such as Protocol Development Process, Case Report Forms (CRFs), Statistical Analysis Plan, Clinical Data Management (CRF Annotation, data Entry, Data Edit checks, Tracking of queries and resolutions, Coding of Adverse Events and Concomitant Medications, Quality Assurance of Database, Database Clean-up, Database lock, Data transfer to sponsor, Database unlock and re-lock), Statistical Analysis & Reporting (Programming of Safety and Efficacy Tables, Listings, and Figures, Unblinding of Randomization Code, Integrated Analysis), Release of Clinical Trials Analysis Results, Medical Writing (Pre-Meeting NDA Briefing Package for submission to FDA, Clinical Study Report, Integrated Summary of Safety and Efficacy, Clinical Overview, Statistical Overview, Publishing of Documents in GlobDoc for Electronic Submission), Templates of Protocol, CRF, SAP, CSR, Project timelines and deliverables, etc.
3. Developments in NDA Submissions to FDA/Regulatory Authorities - Brief details (1 hour)This lecture will apprise the participant on development in the documentation of New Drug Application (NDA) submitted to regulatory authority referring to a check list of items included in NDA submissions, On Paper Submissions, Electronic Submission (eNDA, eCTD), Common Technical Document (CTD), SAS Database as transport files, CDISC compliant SAS database, etc.
4. Biostatistics - Training (80 hours)
List of Standard Tables, Listings, and Figures to be programmed
by Biostatistics Participants